MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 18, 2026 · Event occurred Apr 21, 2026
Report 9610773-2026-03823 · MDR key 25209899
Device
Product problems
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE DID NOT DISPLAY THE IMAGE FROM THE RIGHT EYE AND THE IMAGE APPEARED WHITE AND RESEMBLED A STALACTITE CAVE. THE ISSUE OCCURRED DURING A LAPAROSCOPIC GASTROINTESTINAL ANASTOMOSIS THERAPEUTIC PROCEDURE WHILE THE DEVICE WAS INSIDE THE PATIENT UNDER SEDATION. IT WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.